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510(k) K160417

Rezum System by Nxthera, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2016
Date Received
February 16, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Nxthera, Inc.

  • K180237 — Rezum System (February 27, 2018)
  • K150786 — Rezum System (August 27, 2015)

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